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More digital services on DKMAnet: company authorisations, clinical trials and follow-up on adverse reaction reports

21 November 2011

We are pleased to announce the expansion of the Danish Medicines Agency's extranet, DKMAnet, which offers electronic self-service solutions for companies. DKMAnet is expanded today, 21 November, with three new areas:

  • company authorisations,
  • clinical trials of medicines for human use, and
  • follow-up on adverse reaction reports.

Almost 600 companies in Denmark and abroad already use DKMAnet to report information about product range through the service Prices & Packages, to upload package leaflets, apply for general reimbursement and submit applications for authorisation of retail sale of medicines.

With the expansion, tedious paper flows are replaced by quick, electronic services. The new services are relevant for companies already using DKMAnet, but they are also aimed at other companies that handle medicines in various ways.

Along with the new services, DKMAnet is relaunched in new colours and a more user-friendly service navigation, all of which enhances coherence with the Danish Medicines Agency's website. All previous functionality is preserved, and we hope that the new design will bring improvements for all our users.

How to access the new services

To access the new services, companies that already use DKMAnet must switch to a new user administration model. As part of this model, we introduce a new role: DKMAnet Security Administrator.

There is much to gain from the new user administration model:

  • The company will gain access to new services as they are added without having to contact the Danish Medicines Agency every time.
  • It makes it possible to assign differentiated access to the various DKMAnet areas internally in the company.
  • The company's Security Administrator gets access to an activity log and can monitor the company's activities on DKMAnet.

If you want to gain access to the new services, simply complete and submit the "Form for Appointment of Security Administrator" (to be completed by current and new users). We kindly ask you to also to read the new user administration guidelines.

Please find the documents to the right.

The new services

Company authorisations

Pharmaceutical companies can now apply for the following company authorisations via DKMAnet:

  • manufacture and import of medicines and intermediates (GMP)
  • wholesale distribution of medicines (GDP)
  • activities with euphoriant substances (EUF)
  • conduct of toxicological and pharmacological trials (GLP).

Read more under Company authorisations.

Clinical trials

Pharmaceutical companies, including CROs (Contract Research Organisations), can now apply for and submit notifications about clinical trials in humans via DKMAnet.

It is possible to:

  • apply for a new clinical trial authorisation
  • apply for amendment of an authorised clinical trial
  • submit documentation in connection with the safety surveillance of an authorised clinical trial (e.g. annual safety reports, change of clinical trial status)
  • submit notifications about an authorised clinical trial (e.g. change of investigator, change of CRO)

Read more under Applying for clinical trial authorisations via DKMAnet.

Follow-up on adverse reaction reports

Pharmaceutical companies can now use DKMAnet to submit follow-up questions on adverse reaction reports.

Read more under Follow-up on adverse reaction reports.